Health Condition 1: null- Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: Ex- vivo cultured adult allogeneic Mesenchymal Stem Cells: Single IV infusion
Control Intervention1: Plasmalyte - A: Plasmalyte-A (Placebo) - Single IV infusion
Sponsors
Stempeutics Research Pvt Ltd
Manipal Acunova Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be diagnosed, suffering from chronic obstructive pulmonary disease (COPD) as per GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines and radiological evidence suggestive of predominant emphysema. 2. Patients must be diagnosed as central acinar emphysema. 3. Patient must have a post-bronchodilator FEV1 % predicted value ≥ 30% and 80%. 4. Patient must be above 35 years of age, of either sex 5. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study 6. Patient must be a ex-smoker (quit smoking for ≥ 6 months), with a cigarette smoking history of ≥10 pack-years 7. Patient should have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for required follow-up 8. Patients should be willing to give informed consent for VNTR test Note: There is no upper age limit for this trial
Exclusion criteria
Exclusion criteria: 1. Patient has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, Sarcoidosis, active Tuberculosis inclusive of healed tuberculosis, Idiopathic pulmonary fibrosis, Bronchiectasis, or lung cancer) 2. Patient has a known history of α1-Antitrypsin deficiency 3. Patient has had exacerbation of COPD which required hospitalization / oral or parenteral steroids within 4 weeks of screening 4. Patient has documented (Doppler ECHO) history of clinically overt cor-pulmonale, uncontrolled heart failure, pulmonary hypertension due to left heart condition, atrial fibrillation or significant congenital heart defect/disease 5. Patient has initiated pulmonary rehabilitation within 3 months of screening 6. Patient has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years 7. Patient suffering from end stage of a disease. 8. Hb% less than 10 gm%, Serum Creatinine more than or equal to 1.5 mg%, Serum total bilirubin more than or equal to 2mg%, HbA1c more than 6%, leucocytosis (more than 11,000/cmm) 9. Women who are lactating or positive to pregnancy test. 10. Patients tested positive for antibodies to HIV, CMV, and HBsAg & VDRL and HCV RNA 11. Patient enrolled in any other study within 3 months of this study 12. Patient has clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The type of AE(s), number of AE(s) and proportion of patients with AE(s)Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in: â?¢ Improvement in pulmonary function tests from baseline â?¢ Improvement in exercise capability from baseline (six minute walk test) â?¢ Improvement in quality of life Index (St. Georges respiratory questionnaire) â?¢ Reduction in number of exacerbations/hospitalizations due to COPD â?¢ Radiological improvement in High resolution computerized tomography of chest (HRCT) Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed